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A Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Assess the Efficacy and Safety of Orally Administered SP-303 for the Treatment of Diarrhea in Acquired Immunodeficiency Syndrome (AIDS) Patients

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002408
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: April 1999
History of Changes
  Purpose

To evaluate the efficacy, safety, and durability of response of SP-303 in decreasing stool weight in AIDS patients with diarrhea over 6 days of treatment.


Condition Intervention Phase
Diarrhea
HIV Infections
 Drug: Crofelemer
 Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Assess the Efficacy and Safety of Orally Administered SP-303 for the Treatment of Diarrhea in Acquired Immunodeficiency Syndrome (AIDS) Patients

Resource links provided by NLM:

MedlinePlus related topics: Diarrhea HIV/AIDS
Drug Information available for: Crofelemer
U.S. FDA Resources

Further study details as provided by NIH AIDS Clinical Trials Information Service:

Estimated Enrollment: 300
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

Patients must have:

  • HIV infection meeting CDC criteria for AIDS.
  • History of diarrhea for greater than or equal to 14 days prior to screening period (Day 1).

Required:

- On stable medical regimen.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002408

  Show 36 Study Locations
Sponsors and Collaborators
Shaman Pharmaceuticals
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00002408     History of Changes
Other Study ID Numbers: 293A, 37,554-210
Study First Received: November 2, 1999
Last Updated: June 23, 2005
Health Authority: United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:
Diarrhea
Acquired Immunodeficiency Syndrome

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Diarrhea
Immunologic Deficiency Syndromes
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
 Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immune System Diseases
Signs and Symptoms, Digestive
Signs and Symptoms

ClinicalTrials.gov processed this record on May 19, 2013